Clinical outcomes of grafted vs. percutaneous axillary intra-aortic balloon pump support as a bridge to transplantation: a propensity score-matched analysis.

OBJECTIVES: The purpose of this study is to investigate the early and late outcomes of axillary intra-aortic balloon pump (IABP) implantation as a bridge to heart transplantation, comparing the grafted technique with the percutaneous technique. METHODS: Between July 2009 and January 2020, 163 patients underwent an axillary IABP insertion as a bridge to heart transplantation. Among them, 97 patients underwent axillary IABP implantation through a graft sutured onto the axillary artery (Group A) and 66 patients underwent percutaneously (Group B). Propensity matching identified 53 matched pairs for analysis (C-statistics 0.741). The primary outcomes of interest included IABP-related complications, success rate of a bridge to transplantation, in-hospital mortality, and late survival. RESULTS: In the propensity-score matched cohort, there were no significant differences in the baseline characteristics between the two groups. The operation time was significantly longer in Group A than in Group B (141.5 ± 38.3 min vs 42.7 ± 19.3 min, p < 0.01). The complication rates including stroke, re-exploration for bleeding, and aortic event were not significantly different between Group A and B. However, Group A required more transfusion and re-exploration for bleeding. The success rate of a bridge to transplantation was similar between Group A (47/53, 88.7%) and Group B (47/53, 88.7%). There were no significant differences in in-hospital mortality and late survival between two groups. CONCLUSION: In the propensity score matching analysis, there were not any significant differences between the two groups in IABP-related complications, in-hospital mortality, and late survival. The percutaneous technique provided a shorter operation time and less requirement of transfusion and re-exploration for bleeding compared to the grafted technique. The percutaneous technique might be favorable when feasible.

Proximal ascending aorta size is associated with the incidence of de novo aortic insufficiency with left ventricular assist device.

We sought to assess the impact of the aortic root geometry on developing de novo aortic insufficiency (AI) in patients undergoing left ventricular assist device (LVAD). In total, 114 patients underwent LVAD implantation between February 2016 and January 2020 were included in this study (HeartMate3 N = 68, HeartWare N = 46). Significant aortic insufficiency was defined as mild-to-moderate or greater in echocardiography. The cohort was divided into two groups; those who developed significant AI (Group AI: n = 13) and did not (Group non-AI: n = 101). The primary outcomes of interest included late survival and predictors for significant AI. The patients in Group AI were older than Group non-AI (62.6 ± 11.9 vs 51.3 ± 14.0 years, p < 0.01). The diameter of proximal ascending aorta in Group AI was larger than Group non-AI (31.0 ± 5.0 vs 27.4 ± 4.3 mm, p < 0.01). Aortic valve remained closed in 53.8% in Group AI and 36.6% in Group non-AI (p = 0.24). The late survival was not significantly different between the groups (67.1% vs 76.0% at 3 years, log rank = 0.97). The Cox hazard model showed that larger proximal ascending aortic diameter/BSA (HR 1.55, CI 1.19-2.04, p < 0.01) and not-opening aortic valve (HR 4.73, CI 1.43-16.9, p = 0.01) were independent risk factors for significant AI. The cutoff value of proximal ascending aortic diameter/BSA was 15.5 (area under curve: 0.770, sensitivity: 0.69, specificity: 0.79). Dilated proximal ascending aorta at the time of LVAD surgery and not-opening aortic valve during follow-up were associated with the incidence of de novo significant AI.

Significant vascular complications in percutaneous axillary intra-aortic balloon pump.

OBJECTIVE: Axillary Intra-aortic balloon pump (IABP) has been increasingly utilized for hemodynamic support in heart failure patients. Vascular complications associated with axillary IABP such as dissection or rupture are relatively rare but not negligible that could negatively affect clinical outcomes. We summarized our experiences. METHODS: This is a retrospective study reviewing of all patients receiving an axillary IABP between June 2016 and November 2020. A total of 199 patients underwent percutaneous axillary IABP placement. 6 patients (6/199, 3.0%) were complicated with arterial/aortic dissection or rupture during the procedures or the course of treatment. We described their clinical presentations and outcomes. RESULTS: Vascular complications included acute type A aortic dissection in 2 patients, descending aortic rupture in 1 patient, abdominal aortic rupture along with type B aortic dissection in 1 patient, and the localized left subclavian artery dissection in 2 patient. 2 type A aortic dissection cases were surgically treated: 1 with emergent left ventricle assist device and ascending aorta replacement, the other with emergent left ventricle assist device. Emergent endovascular treatment was successfully performed in 2 aortic rupture cases. The left subclavian artery dissection cases were managed medically. The postoperative/treatment course was uneventful in all patients. CONCLUSION: Percutaneous axillary IABP therapy can cause significant vascular complications. Early diagnosis and prompt treatment would be the key to improve the clinical outcomesv.

Surgical device exchange provides improved clinical outcomes compared to medical therapy in treating continuous-flow left ventricular assist device thrombosis.

The purpose of this study is to compare clinical outcomes of left ventricular assist device (LVAD) patients with device thrombosis who underwent device exchange (DE) or medical therapy (MT) alone. Consecutive patients undergoing LVAD implant between July 2008 and December 2017 were included. Device thrombosis was diagnosed with comprehensive assessments including ramp test, laboratory data, device parameters, and clinical presentations. First, MT was initiated in all patients. After MT, DE was considered if device thrombosis was refractory to initial MT, and it caused end-organ impairment and/or hemodynamic instability. Among 319 consecutive LVAD patients, 43 patients (13.5%) were diagnosed with device thrombosis. DE was performed in 28 patients (DE group); device explant was performed in 1 patient. MT was continued in 14 patients (MT group). In-hospital mortality was significantly lower in the DE group than the MT group (3.6% [1/28] vs. 28.6% [4/14], P = .0184). One-year survival was significantly better in the DE group (74.0% vs. 30.1%; log-rank = .001), and freedom from cerebrovascular accident (CVA) at 1 year was greater in the DE group (87.1% vs. 47.7%; log-rank = .004). DE was associated with improved 1-year survival and fewer CVAs. Surgical intervention, if feasible, is recommended for LVAD device thrombosis.

Correction to: A subcostal approach is favorable compared to sternotomy for left ventricular assist device exchange.

In the original publication, the title of the article was published incorrectly.

Improvement in Biventricular Cardiac Function After Ambulatory Counterpulsation.

BACKGROUND: The NupulseCV intravascular ventricular assist system (iVAS), which consists of a durable pump placed through the subclavian artery, provides extended-duration ambulatory counterpulsation. This study investigated the effect of iVAS on biventricular cardiac function. METHODS AND RESULTS: We reviewed all heart failure patients who received iVAS implantation as a bridge to transplantation or a bridge to candidacy since April 2016 as part of the iVAS first-in-humans and subsequent feasibility study. We compared data of transthoracic echocardiography performed just before implantation (without iVAS support) and again at 30 days or just before explantation (on iVAS support). Eighteen patients (58.8 ± 7.4 years old and 15 male) received iVAS support for 53 ± 43 days. Fourteen patients were bridged to cardiac replacement therapy after 35 ± 19 days and the remaining 4 patients had been supported for 118 ± 41 days. There were no deaths during iVAS support. At 30 days, there was a significant improvement in left ventricular ejection fraction (16.5% ± 11.9% vs 24.4% ± 12.8%; P = .007) and marked reduction in left atrial size (62.7 ± 35.7 mL/m2 vs 33.8 ± 17.2 mL/m2; P < .001). Right ventricular fractional area change improved dramatically (25.4% ± 12.9% vs 42.1% ± 12.4%; P < .001). All other right ventricular and right atrial parameters improved significantly as well (size, tricuspid annular plane systolic excursion, and velocity of tricuspid annular systolic motion). CONCLUSIONS: Improvement in biventricular cardiac function was observed after 30 days of iVAS support. Further studies should examine the use of this technology as a bridge to recovery.

A subcostal approach is favorable compared to sternotomy for left ventricular assist device exchange field of research: artificial heart (clinical).

This is a single-center retrospective study to summarize clinical outcomes of patients requiring surgical continuous-flow left ventricular assist device (HeartMate II) exchange. The patients who underwent HeartMate II exchange were divided into two groups either via a subcostal approach (SC group) or a full sternotomy (FS group). The exclusion criteria of a subcostal approach for device exchange included the presence of outflow graft obstruction, and/or the need for concomitant cardiac procedures. Among 277 consecutive patients who underwent HeartMate II implantation from July 2008 to December 2015, 25 patients (9.0%) required device exchange (SC group; N = 13, FS group; N = 12). The SC group, compared to the FS group, had a shorter operative time (200.6 ± 31.4 min vs 534.2 ± 123.9 min; P < 0.001), shorter cardiopulmonary bypass time (33.1 ± 22.0 min vs 151.5 ± 53.1 min; P < 0.001), fewer blood transfusion (0.31 ± 0.48 units vs 4.67 ± 3.65 units; P = 0.002). The SC group had lower incidence of postoperative prolonged intubation (> 24 h) (7.7% vs 90.9%, P < 0.001), tracheostomy (0.0% vs 41.7%, P = 0.015), acute kidney injury requiring dialysis (0.0% vs 33.3%, P = 0.039). In-hospital mortality was 0.0% (0/13) in the SC group and 16.7% (2/12) in the FS group (P = 0.220). In conclusion, a subcostal approach was associated with shorter operative time, fewer blood transfusions, and less postoperative complications, compared to full sternotomy. A subcostal approach, if feasible, is preferred for HeartMate II device exchange.

Consequences of Retained Defibrillator and Pacemaker Leads After Heart Transplantation-An Underrecognized Problem.

BACKGROUND: Cardiovascular implantable electronic devices (CIEDs) are common in patients undergoing heart transplantation (HT), and complete removal is not always possible at the time of transplantation. METHODS: We retrospectively assessed the frequency of retained CIED leads and clinical consequences in consecutive HT patients from 2013 to 2016. Clinical outcomes included bacteremia, upper-extremity deep venous thrombosis (UEDVT), lead migration, and inability to perform magnetic resonance imaging (MRI). RESULTS: A total of 138 patients (55 ± 11 years of age, 76% male) were identified; 37 (27%) had retained lead fragments (RLFs) at discharge. Patients with RLFs were older, had longer lead implantation time before HT, and a higher prevalence of dual-coil CIED leads compared with those without RLFs (P < .05 for all). Lead implantation time was identified as an independent predictor for RLFs (P < .05). Patients with RLFs had a higher frequency of DVT compared with the non-RLF group during the 1-year study period (42% vs 21%; P < .04). There was no difference in bacteremia. Fourteen patients (38%) could not undergo clinically indicated MRI. CONCLUSION: RLFs after HT occur commonly and are associated with a higher rate of UEDVT and limit the use of MRI. Although no significant difference was found in the rates of bacteremia between the groups, this finding might be explained by the overall low incidence. Patients with risk factors for RLFs should be identified before transplantation, and complete lead removal should be considered with a multidisciplinary approach.

Hybrid convergent procedure with proactive oesophageal cooling for the treatment of long-standing persistent atrial fibrillation: a case series.

Background: The hybrid convergent procedure is approved to treat symptomatic patients with long-standing persistent atrial fibrillation (AF). Despite direct visualization during surgical ablation as well as the use of luminal oesophageal temperature (LET) monitoring, oesophageal injury is still possible. A dedicated device for proactive oesophageal cooling has recently been cleared by the Food and Drug Administration to reduce the likelihood of ablation-related oesophageal injury resulting from radiofrequency cardiac ablation procedures. This report describes the first uses of proactive oesophageal cooling for oesophageal protection during the epicardial ablation portion of hybrid convergent procedures. Case summary: Five patients with long-standing persistent AF underwent hybrid convergent ablations with the use of proactive oesophageal cooling as means of oesophageal protection. All cases were completed successfully with no adverse effects. Most notably, cases were shorter when compared to cases using LET monitoring, likely due to lack of pauses for overheating of the oesophagus that would otherwise be required to prevent damage to the oesophagus. Discussion: This report describes the first uses of proactive oesophageal cooling for oesophageal protection during the epicardial ablation portion of five hybrid convergent procedures. Use of cooling enabled uninhibited deployment of lesions without the need to pause energy delivery due to elevated temperatures in the oesophagus, providing a feasible alternative to LET monitoring.

Impact of prophylactic donor heart tricuspid valve annuloplasty on outcomes in heart transplantation.

BACKGROUND: Tricuspid regurgitation(TR) following heart transplantation could adversely affect clinical outcomes. In an effort to reduce the incidence of TR, prophylactic donor heart tricuspid valve annuloplasty has been performed during heart transplantation in our institution. We assessed early and long-term outcomes. METHODS: Between August 2011 and August 2021, 349 patients who underwent prophylactic tricuspid valve annuloplasty were included. Tricuspid valve annuloplasty was performed using the DeVega annuloplasty technique. The clinical outcomes of the interests included complete atrioventricular block requiring pacemaker implantation, the occurrence of significant TR(defined as moderate or greater), and survival. Long-term survival was compared in patients with and without significant TR using the Kaplan-Meier method. The Cox proportional hazards regression with time-dependent covariate analysis was used to see if significant TR affected the long-term survival. RESULTS: There was one patient(0.3%) who required pacemaker implantation for complete atrioventricular block. No patients developed tricuspid valve stenosis that required intervention. Significant TR developed in 31 patients(8.9%) during the follow-up period. The survival rate of patients who developed significant TR was significantly lower than that of those who did not(log rank < 0.01). Significant TR was associated with the long-term mortality(HR2.92, 95%CI 1.47-5.82, p < 0.01). CONCLUSIONS: Prophylactic donor heart tricuspid valve annuloplasty has the potential to reduce the occurrence of significant TR and can be performed safely. The significant TR that developed in patients with prophylactic annuloplasty negatively affected survival and was an independent predictor of long-term mortality.

Concomitant left atrial appendage closure during left ventricular assist device surgery can reduce ischaemic cerebrovascular accidents.

OBJECTIVES: It remains unknown if the left atrial appendage closure (LAAC) at the time of left ventricular assist device (LVAD) surgery can reduce ischaemic cerebrovascular accidents. METHODS: Consecutive 310 patients who underwent LVAD surgery with HeartMate II or 3 between January 2012 and November 2021 were included in this study. The cohort was divided into 2 groups: patients with LAAC (group A) and without LAAC (group B). We compared the clinical outcomes including the incidence of cerebrovascular accident between 2 groups. RESULTS: Ninety-eight patients were included in group A, and 212 patients in group B. There were no significant differences between 2 groups in age, preoperative CHADS2 score and history of atrial fibrillation. In-hospital mortality did not differ significantly between the 2 groups (group A: 7.1%, group B: 12.3%, P = 0.16). Thirty-seven patients (11.9%) experienced ischaemic cerebrovascular accident (5 patients in group A and 32 patients in group B). The cumulative incidence from ischaemic cerebrovascular accidents in group A (5.3% at 12 months and 5.3% at 36 months) was significantly lower than that in group B (8.2% at 12 months and 16.8% at 36 months; P = 0.017). In a multivariable competing risk analysis, LAAC was associated with reducing ischaemic cerebrovascular accidents (hazard ratio 0.38, 95% confidence interval 0.15-0.97, P = 0.043). CONCLUSIONS: Concomitant LAAC in LVAD surgery can reduce ischaemic cerebrovascular accidents without increasing perioperative mortality and complications.

Ten-year, single center experience of ambulatory axillary intra-aortic balloon pump support for heart failure.

BACKGROUND: The axillary intra-aortic balloon pump has an advantage over the femoral intra-aortic balloon pump in terms of mobility. While axillary intra-aortic balloon pump has been widely used recently as a mode of mechanical circulatory support, the number of reported cases is limited. The purpose of this study is to summarize our experience and to evaluate the safety and efficacy of axillary intra-aortic balloon pump support. METHODS: Between July 2009 and July 2019, 241 patients underwent axillary intra-aortic balloon pump support for heart failure. The intended therapeutic goals were bridge to heart transplantation (n=146), left ventricular assist device (n=66), and recovery (n=29). Intra-aortic balloon pumps were inserted through a graft sutured onto the axillary artery in 142 patients (58.9%) and percutaneously in 99 patients (41.1%). It was placed from the right axillary artery in 147 patients (61.0%) and left in 94 patients (39.0%). Primary outcome measures of interest included achievement of intended therapeutic goal, hemodynamic data, ambulatory data, intra-aortic balloon pump-related death, and complications. RESULTS: Ambulation was possible in 217 patients (90.0%) during support. Hemodynamic parameters improved significantly after axillary intra-aortic balloon pump support. In total, 13 patients (5.4%) died and 10 patients (4.1%) required escalation of mechanical support. There were no deaths directly attributable to intra-aortic balloon pumps. Intra-aortic balloon pump-related stroke occurred in 6 patients (2.5%). Overall, 86.7% were successfully bridged to intended therapy (transplantation 90.4%, left ventricular assist device 90.9%, and recovery 58.6%). CONCLUSIONS: Axillary intra-aortic balloon pumps allow most patients to ambulate during support, improve hemodynamics, and lead to the intended goals successfully.

Comparing short-term/long-term outcomes of heart transplants that occur inside and outside of normal working hours.

AIMS: Heart transplantation involves many factors such as donor selection, recipient management, multidisciplinary assessment, coordination with other organ teams, and transportation. Because of some unpredictable factors, heart transplantation can be conducted at any time of day. The purpose of this study is to investigate if outcomes differ between heart transplants taking place inside or outside of normal working hours. METHODS AND RESULTS: We reviewed patients who underwent heart transplantation at our institution from January 2010 to July 2020 (n = 329). Based on the documented start time of the recipient surgeries, the cohort was divided into two groups: working hours (Group A: 7:30 to 17:00; n = 92) and after hours (Group B: 17:00 to 7:30; n = 237). We compared these groups using propensity score matching analysis. After propensity score matching, 78 pairs of patients were successfully matched. We reviewed early and late clinical outcomes including survival. Long-term survival was compared using the Kaplan-Meier method. In the propensity-score matched patients, there were no significant differences in the baseline characteristics between two groups. In-hospital mortality was not significantly different between the two groups (Group A: 6.4% vs. Group B: 2.6%, P = 0.44). Ischaemic time and cross-clamp time did not differ between the groups. In terms of postoperative complications, there were no significant differences between two groups in stroke (6.4% vs. 3.9%, P = 0.72), primary graft dysfunction requiring extracorporeal membrane oxygenation (5.1% vs. 7.7%, P = 0.75), re-exploration for bleeding (9.0% vs. 12.8%, P = 0.44), and newly required haemodialysis (7.7% vs. 6.4%, P = 0.75). The survival rate in Group A (88.1% at 1 year, 81.3% at 3 years) was not significantly different from Group B (90.5% at 1 year, 82.3% at 3 years, log rank = 0.96). CONCLUSION: There was no significant difference in clinical outcomes between heart transplants taking place inside or outside of working hours. A high quality of care can be provided for heart transplant patients even during after hours.

Outcomes of Ambulatory Axillary Intraaortic Balloon Pump as a Bridge to Heart Transplantation.

BACKGROUND: The axillary intraaortic balloon pump (IABP) is frequently used in selected patients for circulatory support as a bridge to heart transplantation. The purpose of this study was to investigate the safety and efficacy of axillary intraaortic balloon pump (IABP) support for heart transplant candidates. METHODS: The study investigators collected data on 133 patients who underwent axillary IABP support as a bridge to transplantation from July 2009 to April 2019. Of these patients, 94 (70.7%) underwent IABP insertion with surgical axillary grafts, and 39 (29.3%) underwent percutaneous IABP insertion. The outcomes of interest included ambulatory data, IABP-related complications, and successful heart transplantation with this type of support. RESULTS: The overall preoperative ejection fraction was 20.3% ± 8.0%. The median duration of axillary IABP support was 21days, with 131patients (98.5%) mobilizing with the device. Hemodynamic variables significantly improved after the axillary IABP support was placed. Overall, 122 patients (91.7%) were successfully bridged to heart transplantation. Six patients (4.5%) required escalation to further mechanical support. Two patients (1.5%) died while awaiting transplantation. Four patients (3.0%) experienced a stroke during axillary IABP support (3 before transplantation and1 after transplantation). Two of the 3 patients with a stroke diagnosis before transplantation recovered and eventually underwent heart transplantation. CONCLUSIONS: With axillary IABP support, most patients were able to ambulate and undergo physical rehabilitation while waiting for heart transplantation. This study demonstrates that axillary IABP results in a high success rate of bridge to transplantation and a low number of complications. Thus, an ambulatory axillary IABP provided efficient and safe support for selected patients as a bridge to heart transplantation.

Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial.

BACKGROUND: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery. METHODS: We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial. RESULTS: Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25-87) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support. CONCLUSIONS: This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02645539.

Increasing heart transplant donor pool by liberalization of size matching.

BACKGROUND: The heart transplant (HT) guidelines recommendation to match recipient and donors within 30% of body weight lacks a strong evidence base and is not well established in patients bridged to transplant with left ventricular assist devices (LVAD). In light of the scarcity of donor hearts, we investigated the effect of size mismatch on hemodynamics, one-year survival and length of stay (LOS) following HT. METHODS: Single-center retrospective analysis of consecutive HT patients from April 2007 to September 2017. Recipients were divided into 3 cohorts based on donor-to-recipient weight ratio (DRWR): (1) undersized (<0.7), (2) size-matched, (0.7-1.3); (3) oversized (>1.3). RESULTS: 288 consecutive patients were identified (mean age 53 ± 11 years; 76% male), 46 were undersized (0.61 ± 0.05), 210 size-matched (0.94 ± 0.16), and 32 oversized (1.65 ± 0.38). There was no significant difference in donor left ventricular end diastolic diameter (LVEDD) between the 3 groups (p = 0.11). The donor/recipient (D/R) predicted heart mass (PHM) was lowest in the undersized group (0.92 ± 0.13). There were no significant differences in 1-year survival in the overall and LVAD cohort (p = 0.65 and 0.59, respectively). Neither donor LVEDD nor D/R PHM differed among survivors or non-survivors. LOS was longer in the undersized group than the size-matched cohort (p = 0.004). The undersized group had hearts with the highest filling pressures and lowest cardiac index at 1 week among the remaining groups (p = 0.009, 0.017, and p = 0.05, respectively). There were no clinically significant differences in hemodynamics at 1 or 6 months. CONCLUSIONS: HT undersizing affects hemodynamics early but not later in the course and does not impact 1-year survival. The liberalization of size matching may increase the HT donor pool significantly.

The first-in-human experience with a minimally invasive, ambulatory, counterpulsation heart assist system for advanced congestive heart failure.

BACKGROUND: The intravascular ventricular assist system (iVAS) is a new, minimally invasive, ambulatory counterpulsation heart assist system delivered via the subclavian artery and powered by a portable driver. It is designed for recovery, bridge to transplantation (BTT) or for prolonging medical therapy. We report the first-in-human (FIH) experience with iVAS. METHODS: This is a prospective, non-randomized single arm, U.S. Food and Drug Administration (FDA)-approved early feasibility trial in patients listed for cardiac transplantation. The primary end-point was survival to transplant or stroke-free survival at 30 days. RESULTS: Fourteen patients were enrolled and 13 (92.8%) were treated with iVAS. At time of implant, the average age was 58 ± 6.7 years; 85% were male; 28% had ischemic cardiomyopathy; and 3 were Interagency Registry for Mechanically Assisted Devices (INTERMACS) Level 2, 9 were Level 3, and 1 was Level 4. The mean left ventricular ejection fraction was 22%, left ventricular internal diameter diastole was 7.13 mm, and 69% had moderate or severe mitral regurgitation. There were no intra-operative complications. Intensive care unit stay after implant was 6 ± 6 days. All patients were transplanted after 32 ± 21 days. There were no deaths or thromboembolic events: 1 patient required escalation of mechanical support, and post-implant complications included pleuritis/pericarditis (n = 1) and neuropathy (n = 2). No intra-operative blood transfusions were required. CONCLUSIONS: This study demonstrates a high rate of successful outcomes with an excellent risk-to-benefit profile. This FIH experience reveals that the iVAS can be successfully inserted in a standardized approach, provide hemodynamic support, can be interrupted for short periods, and allows for ambulation. A multicenter trial to investigate effectiveness and safety is warranted.

Impact of Residual Valve Disease on Survival After Implantation of Left Ventricular Assist Devices.

BACKGROUND: This retrospective single-institutional study investigated the effect of significant valvular regurgitation after left ventricular assist device (LVAD) implantation and the role of concomitant valve surgery during LVAD surgery. METHODS: All patients receiving an LVAD (HeartMate II; Abbott, Abbott Park, IL) during 2008 and 2015 were enrolled. The cohort was divided into two groups based on the valve status at the end of the operation: patients without significant valvular regurgitation (no-VR) and those with significant valvular regurgitation (residual-VR). RESULTS: An LVAD was implanted in 270 patients. Of these, 233 had significant preoperative valve disease(s), and 180 (66.6%) received concomitant valve interventions (35 aortic, 90 mitral, 138 tricuspid). At the completion of the LVAD operation, 204 had no-VR and 66 had residual-VR. Short-term outcomes were similar in two groups, except for longer cardiopulmonary bypass time in the no-VR group (149 minutes) than in the residual-VR group (132 minutes, p = 0.038). During follow-up, mean pulmonary artery pressure (24 mm Hg in no-VR vs 27 mm Hg in residual-VR; p = 0.018) and pulmonary vascular resistance (1.8 Wood units in no-VR vs 2.7 Wood units in residual-VR, p = 0.008) significantly improved in no-VR group compared with the residual-VR group. Survival and heart failure admission-free rates at 1 year were significantly superior in the no-VR group compared with the residual-VR group (1-year survival: 72% ± 3% No-VR vs 55% ± 6% residual-VR; log-rank p = 0.026; admission-free survival: 91% ± 2% no-VR vs 74% ± 7% residual-VR; log-rank p = 0.026). Concomitant valve intervention was not an independent predictor of in-hospital death and morbidity. CONCLUSIONS: Absence of valvular lesion after LVAD implantation was associated with improved midterm hemodynamics and survival in the current study. Aggressive surgical intervention for significant valve disease(s) at the time of LVAD implant may be beneficial to selected patients.

Surgically Corrected Mitral Regurgitation During Left Ventricular Assist Device Implantation Is Associated With Low Recurrence Rate and Improved Midterm Survival.

BACKGROUND: Indications for concomitant intervention for mitral regurgitation (MR) during left ventricular assist device (LVAD) implantation remain controversial. The objective of this study was to determine the impact of the surgical correction of MR during LVAD implantation. METHODS: From July 2008 to December 2014, 164 patients with significant preoperative MR underwent LVAD (HeartMate II; Thoratec, Pleasanton, CA) implantation. The MR resolved after LVAD implantation in 110 of 164 patients (67.1%) with either surgical or spontaneous correction. The cohort (n = 110) without significant postoperative MR was divided into two groups: a spontaneous correction group (n = 54, MR spontaneously resolved after LVAD implantation); and a surgical correction group (n = 56, MR surgically corrected). Patients who received aortic valve procedures (n = 17) were excluded from this study. RESULTS: Patient demographics, perioperative outcomes including bleeding, prolonged intubation, and stroke, and inhospital mortality did not differ in the two groups except for significantly longer cardiopulmonary bypass time in the surgical correction group (spontaneous correction 123 minutes [interquartile range (IQR): 107 to 150] versus surgical correction 177 minutes [IQR: 132 to 198], p < 0.001). During follow-up, pulmonary wedge pressure (spontaneous correction 17 mm Hg [IQR: 12 to 23 mm Hg] versus surgical correction 12 mm Hg [IQR: 4 to 17 mm Hg], p = 0.015) and pulmonary vascular resistance (spontaneous correction 2.0 Wood units [IQR: 1.5 to 2.4] versus surgical correction 1.7 Wood units [IQR: 0.8 to 2.1], p = 0.047) were significantly improved in the surgical correction group compared with the spontaneous correction group. Overall survival rate and freedom from recurrent MR were significantly better in the surgical correction group compared with the spontaneous correction group (1-year survival, spontaneous correction 59.4% ± 6.9% versus surgical correction 69.6% ± 6.4%, log rank p = 0.030; 1-year freedom from recurrent MR, spontaneous correction 76.2% ± 7.5% versus surgical correction 95.0% ± 3.5%, log rank p = 0.028). CONCLUSIONS: The LVAD patients with surgically corrected MR had improved midterm hemodynamics and survival compared with spontaneously resolved MR, along with low recurrence of MR. Aggressive surgical mitral valve intervention during LVAD implantation may be recommended.